FDA pumps brakes on Sanofi's $3.7B multiple sclerosis bet, imposing partial hold over liver injuries Fierce Next Gen: Lilly genetic medicine portfolio in 'ramp-up phase,' but progress has exceeded expectations WindTree has the clinical results it wants—but is missing the bull market Lexicon CEO touts ‘wonderful morning’ as diabetic pain drug clears phase 2, teeing up hopeful partnership talks More anguish for Angion as safety signal sinks midphase kidney disease trial With narcolepsy approval a year out, antsy Avadel slashes staff by 50% Fierce Next Gen: ViiV research strategy chief talks risks, rewards of long quest to 'cure' HIV Fierce Next Gen: Amgen avoids 'low-hanging fruit' in quest to tackle undruggable targets Fierce Next Gen: As gene therapies proliferate, pharma and payers look to avoid 'cost shocks' After phase 2 flop, Novo Nordisk says its NASH work is 'still very much on track' Philips taps Biodesix’s blood tests for lung cancer screening system Pfizer's latest $3.2B pandemic vaccine contract suggests private market still a ways off: analysts Hyperfine CEO steps down after one year Featured Story | By Nick Paul Taylor The $3.7 billion centerpiece of Paul Hudson’s R&D strategy for Sanofi has hit a setback. Seeing cases of drug-induced liver injury, the FDA has slapped a partial clinical hold on phase 3 trials of the candidate, raising still more doubts about the merits of Sanofi’s Principia Biopharma takeover. read more |
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Top Stories By Max Bayer Andrew Adams, Ph.D., may no longer qualify for Fortune's 40-under-40 list, but as vice president of neurodegenerative research at Lilly, it’s hard to argue against the seismic implications of the science he’s managing. read more By Gabrielle Masson WindTree Therapeutics has the clinical results it wants—but is missing the bull market, meaning the biotech is exploring strategic options amid the market downturn. read more By Annalee Armstrong “It's a wonderful morning for Lexicon, our scientists, clinicians and the patients and principal investigators,” summed up CEO and Director Lonnel Coats, as the biotech reported results from a phase 2 trial for its diabetic neuropathy therapy. read more By Nick Paul Taylor The setbacks keep coming at Angion Biomedica. Having failed two clinical trials last year, the biotech has now stopped a third study after identifying a potential safety signal that caused it to reassess the risks and benefits of ANG-3070 in patients with established serious kidney disease. read more By Max Bayer Staring down the barrel at a potential year-long wait for full approval for a narcolepsy drug, Avadel is getting antsy with regulators and slashing staff to buoy its cash runway ahead of a commercial launch. read more By Annalee Armstrong Can we cure HIV already? It’s a tough question and one that ViiV Healthcare’s Max Lataillade would love to have a concrete answer for. read more By Gabrielle Masson Where there’s challenge lies opportunity, and Amgen is not letting the idea of undruggable disease targets stop it. read more By Eric Sagonowsky Increasingly, cell and gene therapies are changing the treatment landscape for cancers and rare diseases. But how will the system pay for them? read more By Kevin Dunleavy In a phase 2 trial of Novo Nordisk's Type 2 diabetes drug Ozempic (semaglutide) against nonalcoholic steatohepatitis, the treatment was outdone by placebo by a wide margin. In the study of 71 NASH patients with compensated cirrhosis, only 10.6% saw an improvement in liver fibrosis as opposed to 29.2% on placebo. read more By Conor Hale To gain a clearer picture when screening people for the early signs of lung cancer, Philips is looking to bolster its CT scanning approach with blood-based tests developed by Biodesix. read more By Fraiser Kansteiner Just one day after FDA advisers voted to tweak future COVID-19 booster shots, pandemic powerhouse Pfizer has inked yet another supply deal for its BioNTech-partnered mRNA shot in the U.S. read more By Andrea Park “I am disappointed to have to step back from my role as president and CEO of Hyperfine. It has been an honor to lead the company through our first full year of commercialization and our transition to becoming a publicly listed company,” said Dave Scott, citing personal reasons. read more Resources Sponsored By: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter, strategic consultants in the life sciences Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve. Sponsored By: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored By: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Fierce Biotech Summit September 19-20, 2022 | Boston, MA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 